A Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRCHIVMAB0115-00-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults
Public ClinicalTrials.gov record NCT05627258. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
VRC 615: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB-0115-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Background: HIV causes AIDS, a serious disease that can lead to fatal infections. HIV infection can be controlled but not cured, nor is there a vaccine to prevent it. Antibodies may offer a promising new way to prevent HIV infection. Antibodies are proteins that are naturally made by the body to fight germs. One antibody (VRC01.23LS) has been tested in the lab and was found to block HIV-like viruses. Researchers want to find out if it is safe to inject VRC01.23LS into people. Objective: To test the safety of VRC01.23LS in healthy adults. Eligibility: Healthy people aged 18 to 60 years. Design: Participants were divided into 6 groups: Some got 1 dose of VRC01.23LS. They visited the clinic up to 14 times in 24 weeks. Some got 3 doses, each 12 weeks apart. They had 25 clinic visits over 48 weeks. For some participants, the drug was given through a tube attached to a needle inserted into a vein in the arm. This took about 30 to 90 minutes. Others received the drug as an injection under the skin in a fatty area of the belly, arm, or thigh; each dose may have needed up to 3 individual injections. Participants stayed in the clinic up to 8 hours on the days they received VRC01.23LS. Participants received a thermometer and measuring tool. They checked their temperature daily for 7 days after they received the study drug. They measured any redness, swelling, or bruising at the injection site.
Study identification
- NCT ID
- NCT05627258
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 23 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 29, 2023
- Primary completion
- Jul 16, 2024
- Completion
- Jul 16, 2024
- Last update posted
- Aug 21, 2025
2023 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05627258, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 21, 2025 · Synced Sep 16, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05627258 live on ClinicalTrials.gov.